NDC 22840-1206

Smooth Brome

Bromus Inermis

Smooth Brome is a Intradermal; Percutaneous; Subcutaneous Solution in the Non-standardized Allergenic category. It is labeled and distributed by Greer Laboratories, Inc.. The primary component is Bromus Inermis Pollen.

Product ID22840-1206_7a1449c9-7a47-412d-e053-2991aa0a6649
NDC22840-1206
Product TypeNon-standardized Allergenic
Proprietary NameSmooth Brome
Generic NameBromus Inermis
Dosage FormSolution
Route of AdministrationINTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Marketing Start Date1981-09-15
Marketing CategoryBLA / BLA
Application NumberBLA101833
Labeler NameGreer Laboratories, Inc.
Substance NameBROMUS INERMIS POLLEN
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 22840-1206-1

5 mL in 1 VIAL, MULTI-DOSE (22840-1206-1)
Marketing Start Date1981-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 22840-1206-1 [22840120601]

Smooth Brome SOLUTION
Marketing CategoryBLA
Application NumberBLA101833
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1981-09-15

Drug Details

Active Ingredients

IngredientStrength
BROMUS INERMIS POLLEN.001 g/mL

Pharmacological Class

  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]
  • Non-Standardized Pollen Allergenic Extract [EPC]
  • Increased Histamine Release [PE]
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Pollen [CS]
  • Allergens [CS]

NDC Crossover Matching brand name "Smooth Brome" or generic name "Bromus Inermis"

NDCBrand NameGeneric Name
22840-1205Smooth BromeBromus inermis
22840-1206Smooth BromeBromus inermis
22840-1207Smooth BromeBromus inermis
22840-1239Smooth BromeBromus inermis
22840-1240Smooth BromeBromus inermis
22840-1241Smooth BromeBromus inermis
22840-5201Smooth BromeBromus inermis
36987-2437Smooth BromeSmooth Brome
36987-2438Smooth BromeSmooth Brome
36987-2439Smooth BromeSmooth Brome
36987-2440Smooth BromeSmooth Brome
36987-2441Smooth BromeSmooth Brome
36987-2442Smooth BromeSmooth Brome
36987-2443Smooth BromeSmooth Brome
36987-2444Smooth BromeSmooth Brome
49643-328Smooth Brome PollenBromus inermis

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.